Phase
Condition
Leukemia
Lymphoma
Lymphocytic Leukemia, Chronic
Treatment
Nemtabrutinib
Rituximab
Venetoclax
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Confirmed diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and active disease clearly documented to initiate therapy
Deletion (Del) (17p) status, tumor protein 53 (TP53) mutation status, andimmunoglobulin heavy chain gene (IGHV) mutation status results required beforerandomization for Part 2 participants only
Relapsed or refractory to at least 1 prior available therapy
Have at least 1 marker of disease burden
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization
Has a life expectancy of at least 3 months
Has the ability to swallow and retain oral medication
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible ifthey have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeksand have undetectable HBV deoxyribonucleic acid (DNA) viral load beforerandomization
Participants with history of hepatitis C virus (HCV) infection are eligible if HCVribonucleic acid (RNA) viral load is undetectable at screening
Participants with human immunodeficiency virus (HIV) who meet ALL eligibilitycriteria
Participants with adequate organ function with specimens collected within 7 daysbefore the start of study intervention
If capable of producing sperm, participant agrees to eliminate Nemtabrutinib: 12days, Venetoclax: 1 month (30 days), Rituximab (rituximab biosimilar): notapplicable; abstains from penile-vaginal intercourse as their preferred and usuallifestyle; OR uses prescribed contraception
Participant assigned female sex at birth are eligible to participate if not pregnantor breastfeeding and are not a person of childbearing potential (POCBP) OR is aPOCBP and uses a contraceptive method that is highly effective, has a negativehighly sensitive pregnancy test, and abstains from breastfeeding
Exclusion
Exclusion Criteria:
Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection
Has gastrointestinal (GI) dysfunction that may affect drug absorption
Has a known additional malignancy that is progressing or has required activetreatment within the past 2 years
Has diagnosis of Richter Transformation or active central nervous system (CNS)involvement by CLL/SLL
Has an active infection requiring systemic therapy, such as intravenous (IV)antibiotics, during screening
HIV-infected participants with a history of Kaposi's sarcoma and/or MulticentricCastleman's Disease and/or acquired immune deficiency syndrome (AIDS)-definingopportunistic infection in the past 12 months before screening
Clinically significant cardiovascular disease
Has a known allergy/sensitivity to nemtabrutinib or contraindication tovenetoclax/rituximab (or rituximab biosimilar), or any of the excipients
Has history of severe bleeding disorders (eg, hemophilia)
Has received prior systemic anticancer therapy within 5 half-lives or 4 weeks (ifprior therapy was a monoclonal antibody) before randomization
Has received prior B-cell lymphoma 2 inhibitor(s) (BCL2i) within ≤ 12 months beforerandomization or has received prior radiotherapy within 2 weeks of start of studyintervention, or radiation related toxicities, requiring corticosteroids
Is currently being treated with p-glycoprotein (P-gp) substrates with a narrowtherapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3Astrong inhibitors.
Has received a live or live attenuated vaccine within 30 days before the first doseof study intervention
Has received an investigational agent or has used an investigational device within 4weeks before study intervention administration
Has a known psychiatric or substance use disorder that would interfere with theparticipant's ability to cooperate with the requirements of the study
Participants who have not adequately recovered from major surgery or have ongoingsurgical complications
Study Design
Connect with a study center
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1007)
Mar del Plata, Buenos Aires B7600FZO
ArgentinaSite Not Available
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1007)
Mar del Plata., Buenos Aires B7600FZO
ArgentinaSite Not Available
Instituto Alexander Fleming ( Site 1005)
Ciudad Autónoma de Buenos Aires, Buenos Aires 3435907 C1426ANZ
ArgentinaActive - Recruiting
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1007)
Mar del Plata 3430863, Buenos Aires 3435907 B7600FZO
ArgentinaActive - Recruiting
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Hematology ( Site 1002)
Buenos Aires, Caba C1431FWO
ArgentinaSuspended
Sanatorio Parque ( Site 1003)
Rosario, Santa Fe S2000DVC
ArgentinaSite Not Available
Sanatorio Parque ( Site 1003)
Rosario 3838583, Santa Fe Province 3836276 S2000DSV
ArgentinaActive - Recruiting
Centro Medico Fleischer ( Site 1006)
Buenos Aires, 1414
ArgentinaActive - Recruiting
Hospital Aleman-oncohematologic diseases ( Site 1001)
Buenos Aires, C1118AAT
ArgentinaSite Not Available
Centro Medico Fleischer ( Site 1006)
Buenos Aires 3435910, 1414
ArgentinaActive - Recruiting
Hospital Aleman-oncohematologic diseases ( Site 1001)
Buenos Aires 3435910, C1118AAT
ArgentinaActive - Recruiting
Royal Adelaide Hospital ( Site 1104)
Adelaide, South Australia 5000
AustraliaSite Not Available
Royal Adelaide Hospital ( Site 1104)
Adelaide 2078025, South Australia 2061327 5000
AustraliaActive - Recruiting
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 1103)
Melbourne, Victoria 3021
AustraliaSite Not Available
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 1103)
St Albans, Victoria 3021
AustraliaSite Not Available
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 1103)
Melbourne 2158177, Victoria 2145234 3021
AustraliaActive - Recruiting
UZ Leuven-Hematology ( Site 1200)
Leuven, Vlaams-Brabant 3000
BelgiumSite Not Available
UZ Leuven-Hematology ( Site 1200)
Leuven 2792482, Vlaams-Brabant 3000
BelgiumActive - Recruiting
ZAS Cadix ( Site 1203)
Antwerp 2803138, 2030
BelgiumActive - Recruiting
ZAS Cadix ( Site 1203)
Antwerpen, 2030
BelgiumSite Not Available
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308)
São Paulo, Sao Paulo 01246-000
BrazilSite Not Available
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308)
Sao Paulo, 01246-000
BrazilSite Not Available
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308)
São Paulo 3448439, 01246-000
BrazilSite Not Available
The Moncton Hospital ( Site 1414)
Moncton, New Brunswick E1C 6Z8
CanadaSite Not Available
The Moncton Hospital ( Site 1414)
Moncton 6076211, New Brunswick 6087430 E1C 6Z8
CanadaActive - Recruiting
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 1402)
Greenfield Park, Quebec J4V 2H1
CanadaSite Not Available
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer
Sherbrooke, Quebec J1H 5H4
CanadaSuspended
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 1410)
Sherbrooke, Quebec J1H 5H4
CanadaSite Not Available
Biocenter ( Site 1507)
Concepcion, Biobio 4070196
ChileSite Not Available
Biocenter ( Site 1507)
Concepcion., Biobio 4070196
ChileSite Not Available
Biocenter ( Site 1507)
Concepción, Biobio 4070196
ChileSite Not Available
IC La Serena Research ( Site 1506)
La Serena, Coquimbo 1720430
ChileSite Not Available
IC La Serena Research ( Site 1506)
La Serena., Coquimbo 1700000
ChileSite Not Available
IC La Serena Research ( Site 1506)
La Serena 3884373, Coquimbo Region 3893623 1720430
ChileActive - Recruiting
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509)
Santiago, Region M. De Santiago 7500653
ChileActive - Recruiting
Clínica Inmunocel ( Site 1511)
Santiago, Region M. De Santiago 7580206
ChileActive - Recruiting
FALP-UIDO ( Site 1500)
Santiago, Region M. De Santiago 7500994
ChileSite Not Available
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509)
Santiago., Region M. De Santiago 7500653
ChileSite Not Available
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509)
Santiago 3871336, Region M. de Santiago 7500653
ChileActive - Recruiting
Clínica Inmunocel ( Site 1511)
Santiago 3871336, Region M. de Santiago 7580206
ChileActive - Recruiting
FALP-UIDO ( Site 1500)
Santiago 3871336, Region M. de Santiago 7500921
ChileActive - Recruiting
Biocenter ( Site 1507)
Concepción 3893894, Región del Biobío 3898380 4070196
ChileActive - Recruiting
Fundación Valle del Lili ( Site 1703)
Cali, Valle Del Cauca 760032
ColombiaSite Not Available
Fundación Valle del Lili ( Site 1703)
Cali 3687925, Valle del Cauca Department 3666313 760032
ColombiaActive - Recruiting
Fundación Valle del Lili ( Site 1703)
Santiago de Cali 3687925, Valle del Cauca Department 3666313 760032
ColombiaSite Not Available
Hopital Claude Huriez - CHU de Lille ( Site 2107)
Lille, Nord 59037
FranceSite Not Available
Hopital Claude Huriez - CHU de Lille ( Site 2107)
Lille 2998324, Nord 59037
FranceActive - Recruiting
Centre Hospitalier Universitaire Estaing ( Site 2105)
Clermont-Ferrand, Puy-de-Dome 63100
FranceSite Not Available
Centre Hospitalier Universitaire Estaing ( Site 2105)
Clermont-Ferrand 3024635, Puy-de-Dome 63100
FranceActive - Recruiting
CHD Vendee ( Site 2100)
La Roche-sur-Yon, Vendee 85925
FranceSite Not Available
CHD Vendee ( Site 2100)
La Roche-sur-Yon 3006767, Vendee 85925
FranceActive - Recruiting
Klinikum Mutterhaus der Borromäerinnen-Innere Medizin I ( Site 2203)
Trier, Rheinland-Pfalz 54290
GermanySite Not Available
Klinikum Mutterhaus der Borromäerinnen-Innere Medizin I ( Site 2203)
Trier 2821164, Rhineland-Palatinate 2847618 54290
GermanyActive - Recruiting
Universitätsklinikum Leipzig-Medical Department I - Hematology and Celltherapy ( Site 2201)
Leipzig, Sachsen 04103
GermanySite Not Available
Universitätsklinikum Leipzig-Medical Department I - Hematology and Celltherapy ( Site 2201)
Leipzig 2879139, Saxony 2842566 04103
GermanyActive - Recruiting
Rambam Health Care Campus ( Site 2801)
Haifa, 3109601
IsraelSite Not Available
Rambam Health Care Campus ( Site 2801)
Haifa 294801, 3109601
IsraelActive - Recruiting
Hadassah Medical Center-Hemato-Oncology ( Site 2812)
Jerusalem, 9112001
IsraelSite Not Available
Hadassah Medical Center-Hemato-Oncology ( Site 2812)
Jerusalem 281184, 9112001
IsraelActive - Recruiting
Sheba Medical Center-Hemato Oncology ( Site 2809)
Ramat Gan, 5265601
IsraelSite Not Available
Sheba Medical Center-Hemato Oncology ( Site 2809)
Ramat Gan 293788, 5265601
IsraelActive - Recruiting
Sourasky Medical Center ( Site 2811)
Tel Aviv, 6423906
IsraelSite Not Available
Sourasky Medical Center ( Site 2811)
Tel Aviv 293397, 6423906
IsraelActive - Recruiting
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2906)
Alessandria, Ancona 15121
ItalySite Not Available
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare -Azienda Ospedaliera Nazionale SS. Ant
Alessandria, 15121
ItalyActive - Recruiting
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2906)
Alessandria 3183299, 15121
ItalyActive - Recruiting
Ospedale San Raffaele-Programma di Ricerca Strategica sulla LLC ( Site 2902)
Milan 6951411, 20132
ItalyActive - Recruiting
Ospedale San Raffaele-Programma di Ricerca Strategica sulla LLC ( Site 2902)
Milano, 20132
ItalySite Not Available
Arcispedale Santa Maria Nuova-Hematology ( Site 2900)
Reggio Emilia, 42123
ItalySite Not Available
Arcispedale Santa Maria Nuova-Hematology ( Site 2900)
Reggio Emilia 3169522, 42123
ItalyActive - Recruiting
Centro de Infusion Superare ( Site 3314)
Ciudad de México, Distrito Federal 03100
MexicoSite Not Available
Health Pharma Professional Research S.A. de C.V: ( Site 3301)
Ciudad de México, Distrito Federal 03100
MexicoActive - Recruiting
Centro de Infusion Superare ( Site 3314)
Mexico City 3530597, Mexico City 3527646 03100
MexicoActive - Recruiting
Health Pharma Professional Research S.A. de C.V: ( Site 3301)
Mexico City 3530597, Mexico City 3527646 03100
MexicoActive - Recruiting
Centro de Investigacion Clinica Chapultepec ( Site 3309)
Morelia, Michoacan 58260
MexicoSite Not Available
Centro de Investigacion Clinica Chapultepec ( Site 3309)
Morelia 3995402, Michoacán 3995955 58260
MexicoActive - Recruiting
Auxilio Mutuo Cancer Center ( Site 3900)
San Juan, 00918
Puerto RicoSite Not Available
Auxilio Mutuo Cancer Center ( Site 3900)
San Juan 4568127, 00918
Puerto RicoActive - Recruiting
Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 4401)
Moreletta Park, Gauteng 0181
South AfricaSite Not Available
Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 4401)
Moreletapark 8030071, Gauteng 1085594 0181
South AfricaSite Not Available
Alberts Cellular Therapy. ( Site 4401)
Pretoria 964137, Gauteng 1085594 0181
South AfricaActive - Recruiting
Groote Schuur Hospital ( Site 4400)
Cape Town, Western Cape 7925
South AfricaSite Not Available
Groote Schuur Hospital ( Site 4400)
Cape Town 3369157, Western Cape 1085599 7925
South AfricaActive - Recruiting
Haemalife ( Site 4407)
Kuilsriver, Western Cape 1085599 7580
South AfricaActive - Recruiting
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4601)
L'Hospitalet Del Llobregat, Barcelona 08908
SpainActive - Recruiting
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 4602)
Pozuelo de Alarcon, Madrid 28223
SpainSite Not Available
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 4602)
Pozuelo de Alarcón 3112989, Madrid 3117732 28223
SpainActive - Recruiting
HOSPITAL CLINICO DE VALENCIA-HEMATOLOGY ( Site 4603)
Valencia, Valenciana, Comunitat 46010
SpainSite Not Available
HOSPITAL CLINICO DE VALENCIA-HEMATOLOGY ( Site 4603)
Valencia 2509954, Valenciana, Comunitat 46010
SpainActive - Recruiting
Namik Kemal University Medical Faculty-Hematology ( Site 4912)
Tekirdag, Tekirdas 59100
TurkeySite Not Available
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913)
Ankara, 06100
TurkeySite Not Available
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906)
Istanbul, 34722
TurkeySite Not Available
Mega Medipol-Hematology ( Site 4904)
İstanbul, 34214
TurkeyActive - Recruiting
Ege Universitesi Hastanesi ( Site 4902)
İzmir, 35100
TurkeySite Not Available
Namik Kemal University Medical Faculty-Hematology ( Site 4912)
Tekirdağ 738927, Tekirdas 59100
Turkey (Türkiye)Active - Recruiting
Ege Universitesi Hastanesi ( Site 4902)
Bornova 320857, İzmir 311044 35100
Turkey (Türkiye)Active - Recruiting
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913)
Ankara 323786, 06100
Turkey (Türkiye)Active - Recruiting
Mega Medipol-Hematology ( Site 4904)
Istanbul 745044, 34214
Turkey (Türkiye)Active - Recruiting
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906)
Istanbul 745044, 34722
Turkey (Türkiye)Active - Recruiting
Ege Universitesi Hastanesi ( Site 4902)
Izmir 311046, 35100
Turkey (Türkiye)Site Not Available
City Hospital, Nottingham University Hospitals-Hematology ( Site 5002)
Nottingham, England NG5 1PF
United KingdomSite Not Available
City Hospital, Nottingham University Hospitals-Hematology ( Site 5002)
Nottingham 2641170, England 6269131 NG5 1PF
United KingdomActive - Recruiting
University College London Hospital-Cancer Clinical Trials Unit ( Site 5001)
London-Camden, London, City of NW1 2PG
United KingdomActive - Recruiting
Highlands Oncology Group ( Site 5405)
Springdale, Arkansas 72762
United StatesSite Not Available
Highlands Oncology Group ( Site 5405)
Springdale 4132093, Arkansas 4099753 72762
United StatesActive - Recruiting
MemorialCare Health System - Long Beach Medical Center ( Site 5421)
Long Beach, California 90806
United StatesSite Not Available
MemorialCare Health System - Long Beach Medical Center ( Site 5421)
Long Beach 5367929, California 5332921 90806
United StatesActive - Recruiting
Memorial Hospital West ( Site 5410)
Pembroke Pines, Florida 33028
United StatesSite Not Available
Memorial Hospital West ( Site 5410)
Pembroke Pines 4168139, Florida 4155751 33028
United StatesActive - Recruiting
Oregon Health and Science University ( Site 5425)
Portland, Oregon 97239-3011
United StatesSite Not Available
Oregon Health and Science University ( Site 5425)
Portland 5746545, Oregon 5744337 97239-3011
United StatesActive - Recruiting
Medical Oncology Associates, PS ( Site 5406)
Spokane, Washington 99208
United StatesSite Not Available
Medical Oncology Associates, PS ( Site 5406)
Spokane 5811696, Washington 5815135 99208
United StatesActive - Recruiting
University of Wisconsin Hospital and Clinics-Carbone Cancer Center ( Site 5423)
Madison, Wisconsin 53792
United StatesSite Not Available
University of Wisconsin Hospital and Clinics-Carbone Cancer Center ( Site 5423)
Madison 5261457, Wisconsin 5279468 53792
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.